According to Datla, India is still in the process of drafting its own guidelines.. Getty image

Lack of clarity on India’s commitment to purchase COVID-19 vaccines is creating a challenging environment for those developing them here, according to some of India’s top vaccine makers. Apart from issues with funding, ambiguity regarding the parameters that these vaccines have to measure up to here have also been flagged as a challenge.

“Most manufacturers sitting at this table … we’re doing this at risk,” said Mahima Datla, managing director of Biological E, during a panel discussion on vaccines moderated by Telangana IT and Industries Minister KT Rama Rao on Tuesday. Datla said there is little clarity on the Centre’s interest in purchasing Covid-19 vaccines developed by firms like hers, and there isn’t enough funding to back the risk the industry is taking by working on these new products.

Countries like the US and UK have not only inked purchase agreements worth billions of dollars for vaccine candidates currently in late stage human clinical trials, some have also funded research and development for potential vaccine candidates.

Here, save for a potential participation in the Covid-19 Vaccine Global Access (COVAX) mechanism, there have been no “pull mechanisms” to assuage Indian companies that mostly have candidates in pre-clinical stages of testing, according to the industry.

“The COVAX facility is one way where they’re kind of trying to give you demand certainty but that (type of action) hasn’t been forthcoming from our own government, which is a bit disappointing …,” said Datla.

“We don’t see any pull mechanism because each of us as of now are trying to spend from our own pockets not even knowing how much of this is going to be taken up later. There has to be some mechanism which would help us …,” Dr K Anand Kumar, MD, Indian Immunologicals said.
Dr Krishna Ella, CMD, Bharat Biotech, said an environment to boost development of Covid-19 vaccines is not as robust because different government bodies are working in silos, adding “There’s some strategy discussion missing, leadership is missing in Delhi.”

There are also regulatory challenges like a lack of clear guidelines for Covid-19 vaccines, including what their level of efficacy should be. According to Datla, India is still in the process of drafting its own guidelines.